European Union Adopts final Medical Device Regulation: AMDR urges European Member States to “opt in” to CE marking paradigm for SUD reprocessing

European Union Adopts final Medical Device Regulation: AMDR urges European Member States to “opt in” to CE marking paradigm for SUD reprocessing

Last week marks a milestone for medical device makers, including commercial SUD reprocessors in Europe. After nearly five years of negotiations, the European Union finally passed a comprehensive new EU wide Medical Device Regulation (MDR). For SUD reprocessors, this is a major development as Europe now has in place a “manufacturer” regulatory path for reprocessed SUDs – meaning commercial reprocessors can legitimize their products by demonstrating their products are as safe and meet the same requirements as original equipment. Best of all, with the introduction of CE marked, remanufactured SUDs, hospitals will have access to lower-priced devices which provides competitive downward pricing pressure on manufacturers for new devices. This is good news for healthcare consumers in Europe. In order to access these savings for hospitals and consumers alike, AMDR urges European Member States to “opt in” to this CE marking paradigm for SUD reprocessing to help their hospitals safely save money and reduce waste.

AMDR has actively participated in the negotiations with the European Commission, Council and Parliament. While the final version of the MDR does not include the single, harmonized standard for SUD reprocessing AMDR had hoped for, this Regulation does create a path for commercial firms to demonstrate, scientifically, that their products are safe and effective.

European hospitals can gain dramatic financial savings with reprocessed medical devices – which can cost 30 to 40 percent LESS than new devices. Reprocessed and remanufactured SUDs help hospitals reduce regulated medical waste and waste disposal costs. The stringent requirements for SUD reprocessors will, in AMDR’s view, deter hospitals from reusing SUDs in house, and instead usher in growth for regulated firms that meet the new EU MDR standards. Learn more about the AMDR Position on Final MDR, Article 17 Provisions.